Agenda
• Calculate your serialization costs by holistically examining all elements involved in your implementation strategy
• Consider certain key factors when anticipating implementation costs, including underlying dependencies, validation costs, and lower productivity levels during downtime
• Adjust your budget to accommodate changes in local and international traceability regulations
Considered Elements – Initial Costs
• Plant hardware • IT Hardware (plant, enterprise) • Software licenses (line, plant, enterprise) • Implementation services (line, plant, enterprise) • SOPs new and updates (line, plant, enterprise) • Documentation new and updates (line, plant, enterprise) • Training (line, plant, enterprise) • Validation (line, plant, enterprise) • New printing costs (adjustments to fit new barcode) • Trading partner agreement updates • Product launch impacts • Contractual updates • Risk assessment updates (possible new categories) • Disaster recovery plan updates and new requirements
Considered Elements – Recurring Costs
New support agreements • Hardware • Software • Services
Increased media and supplies cost Increased data creation
• Storage costs • Bandwidth costs
Increased trading partner data exchange volumes • Bandwidth costs
Increased reporting requirements • Storage costs
Increased operational processes • Time impact on COGS
Considered Elements – Incremental Costs
• New product • New packaging formats • New regulatory requirements • Hardware changes/upgrades • Software upgrades • New trading partners • New data exchange requirements • New operational requirements • Artwork changes and approvals • Downtime/Supply chain disruption due to changes
Summary of Costs: Considered Elements
Calculate your serialization costs by holistically examining all element involved in your implementation strategy.
• Packaging lines • Line level
• Hardware • Software • SOPs
• Site level • Systems • Software • Integration • SOPs
• Enterprise level • Systems • Software • Integration • SOPs
• Trading partner integration • Trading partner SOPs • Documentation • Validation • Regulatory reporting • Change management • Support • Training • Downtime • Product availability • Printing space and brand management • Artwork changes and approvals
Key Factors
Every hardware component, software package, network connection, systems interface, integration service, supportive service, and operational service are simultaneously investment buckets and potential points of failure
Key Factors
Production impact • Time • Cost • Risk
Supply chain impact • Product availability • Trading partner data exchange • Trading partner(s) audits for compliance to regulations
Supply & Demand • Hardware availability • Software availability if not GAMP Class 4 • Professional services (limited serialization resources) • Internal resources (competition with other projects)
Key Factors
Line of business application support serialization’s affects on • Inventory control • Master data • Warehouse management • Order management • Reverse logistics
Business Process Changes • Order-to-cash process • Supply chain network compliance • Returns processing • Customer support • Data governance • Regulatory • Exception handling
Key Factors
SOPs • Line level processing for WIP materials • Finished goods inventory processing • Quality assurance
• Sampling • Investigations
• Order fulfillment • Data collection • New product launch • Master data management
Validation • Scope (top-floor to plant-floor integration) • Forward looking where possible • Regulation timeline in phases
Summary - Key Factors
Consider certain key factors when anticipating implementation costs, including underlying dependencies, validation costs, and lower productivity levels during downtime
• Inventory control • Master data • Materials management • Warehouse management • Order management • Supply chain management • Customer support • Returns processing • Trading partner compliance • New product launch • Validation • Quality assurance
• Data governance • Data collection • Exception handling • Data exchange • Regulatory reporting • Systems integration • Professional services • Supportive services • Internal resource conflicts • Product availability • Downtime
Change is inevitable
Adjust your budget to accommodate changes in local and international traceability regulations
Change is inevitable
USA – Requirements will continue to phase in until at least 2023, longer if there are delays or alterations based on the pilots, public meetings, required evaluations, and of course the US Congress.
Change is inevitable
Additional markets are implementing or considering implementing serialization mandates
Change is inevitable
Globalization and consolidation of manufacturing increases the likelihood of additional markets being served and different regulations being met.
Change is inevitable
Global Changes may require: • New hardware additions (e.g. bundle aggregation)
• Software modifications, upgrades, or reconfiguration
• New data exchange formats or content
• Updates to regulatory reporting
• Validation
• Changes in SOPs
• Documentation and training
TCO - Summary
• Serialization is far reaching in its impact • Most serialization pilots and early implementations have ignored business application impacts and integration requirements • Supportive services and after go-live costs can far exceed the initial investment, but are rarely considered up-front • The myriad of touchpoints included in all the parts needed to meet serialization compliance can be daunting, but it is critical to consider them and most importantly understand their impacts on other elements